Medications/Drugs (Outpatient/Part B)

UnitedHealthcare? Medicare Advantage

Coverage Summary

Medications/Drugs (Outpatient/Part B)

Policy Number: MCS057.31

Last Committee Approval Date: June 12, 2024

Effective Date: July 1, 2024

Table of Contents

Page

Coverage Guidelines ............................................................. 1

? Outpatient Medications/Drugs ........................................ 1

? Unlabeled Use of a Part B Drug ..................................... 2

? Medications/Drugs Covered Under Part B ..................... 2

? Medications/Drugs Not Covered..................................... 9

? Review at Launch ......................................................... 10

? Step Therapy Program ................................................. 10

? Maximum Dosage and Frequency................................ 10

? Other Specific Medications ........................................... 10

Definitions............................................................................ 11

Supporting Information ........................................................ 12

Policy History/Revision Information .................................... 30

Instructions for Use ............................................................. 31

? Instructions for Use

Related Medicare Advantage Policy Guidelines

? Halaven? (Eribulin Mesylate)

? Immune Globulin

? Testosterone Pellets (Testopel?)

? Xgeva?, Prolia? (Denosumab)

Coverage Guidelines

Outpatient/Part B medications/drugs are covered when Medicare coverage criteria are met.

DME Face-to-Face Requirement: Section 6407 of the Affordable Care Act (ACA) established a face-to-face encounter

requirement for certain items of DME (including implantable infusion pumps, implantable programmable infusion pump,

and external ambulatory infusion pump and nebulizers). For DME Face-to-Face Requirement information, refer to the

Coverage Summary titled Durable Medical Equipment (DME), Prosthetics, Orthotics (Non-Foot Orthotics), Nutritional

Therapy, and Medical Supplies Grid.

Note: The guidelines in this Coverage Summary are for specific procedures/medications only. For procedures/

medications not addressed in this Coverage Summary, refer to the Medicare Coverage Database to search for applicable

coverage policies (National Coverage Determinations, Local Coverage Determinations and Local Coverage Articles).

(Accessed May 21, 2024)

Outpatient Medications/Drugs

Part B Medications/Drugs

Outpatient (Part B) medications/drugs, in accordance with Medicare coverage criteria, are covered when furnished

¡°incident¡± to a physician service for drugs that are ¡°not Usually Self-Administered By the Patient.¡± Refer to the definition of

Not Usually Self-Administered By the Patient.

Coverage is Usually limited to drugs or biologicals Administered by infusion or injection. However, if the injection is

generally Self-Administered (e.g., Imitrex), it is not covered under Part B. Despite the general limitation on coverage for

outpatient drugs under Part B, some Self-Administered medications/drugs are also covered. For examples, refer to the

Medications/Drugs Covered Under Part B and Medications/Drugs Not Covered sections.

For Medicare¡¯s detailed coverage criteria for medications/drugs under Part B, refer to the Medicare Benefit Policy Manual,

Chapter 15, ¡ì50 ¨C Drugs and Biologicals.

(Accessed May 21, 2024)

Medications/Drugs (Outpatient/Part B)

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Part D Medications/Drugs

A Part D covered drug is available only by prescription, approved by the Food and Drug Administration (FDA), used and

sold in the United States, and used for a medically accepted indication.

A drug for which coverage is available under Part A or Part B, as it is being ¡°prescribed and dispensed or Administered¡±

with respect to the individual, is excluded from the definition of a Part D drug and, therefore, cannot be included in Part D

basic coverage. CMS interprets this to mean that if payment could be available under Part A or Part B to the individual for

such drug, then it will not be covered under Part D.

Section 1860D-2(e)(4) of the Act defines ¡°medically-accepted indication,¡± in part by reference to section 1927(k)(6) of the

Act, to any use of a covered Part D drug which is approved under the Federal Food, Drug, and Cosmetic Act, or the use

of which is supported by one or more citations included or approved for inclusion in any of the compendia described in

section 1927(g)(1)(B)(i) of the Act. The recognized compendia are:

American Hospital Formulary Service Drug Information; and

DRUGDEX? Information System.

Refer to the Medicare Prescription Drug Benefit Manual Chapter 6, ¡ì10.6 ¨C Medically Accepted Indication.

Note: Some members may have coverage for Part D drugs under UnitedHealthcare. Refer to the Member¡¯s Pharmacy

Booklet or contact the Prescription Solutions Customer Service Department to determine coverage eligibility for Part D

prescription drug plan benefit.

For Medicare¡¯s detailed coverage information for medications/drugs under Part D, refer to the Medicare Prescription Drug

Benefit Manual, Chapter 6, ¡ì10 ¨C Definition of Part D Drugs.

(Accessed May 21, 2024)

Part B vs. Part D Medications/Drugs

For Part B vs. Part D medications/drugs guidelines, refer to the specific medications listed under the Medications/Drugs

Covered Under Part B section.

Unlabeled Use of a Part B Drug

Unlabeled use of a drug may be covered only if a UnitedHealthcare Medical Director or his/her designee determines the

use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or

accepted standards of medical practice.

Refer to the Medicare Benefit Policy Manual, Chapter 15, ¡ì50.4.2 ¨C Unlabeled Use of Drug.

For the list of the major drug compendia for off-label use of drugs and biologicals in an anti-cancer chemotherapeutic

regimen, refer to the Medicare Benefit Policy Manual, Chapter 15, ¡ì50.4.5.B ¨C Recent Revision to Compendia List.

In the case of drugs used in anti-cancer chemotherapeutic regimen, refer to the Medicare Benefit Policy Manual,

Chapter 15, ¡ì50.4.5 ¨C Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen.

Notes:

The above information is for determining coverage for the unlabeled use of medication covered under Part B only, not

Part D. Refer to the Member¡¯s Pharmacy Booklet or contact the Prescription Solutions Customer Service Department

for further information on Part D coverage, if any.

Definition of Compendium: CMS revised the definition of ¡°compendium¡± to include this public transparency

requirement. In this revised definition, a compendium:

o Includes a summary of the pharmacologic characteristics of each drug or biological and may include information

on dosage, as well as recommended or endorsed uses in specific diseases; and

o Is indexed by drug or biological; and

o Has a publicly transparent process for evaluating therapies and for identifying potential conflicts of interests.

Refer to the Medicare Benefit Policy Manual, Chapter 15, ¡ì50 ¨C Drugs and Biologicals ¡ì50.4.5.1.A.

(Accessed May 21, 2024)

Medications/Drugs Covered Under Part B

Examples medications/drugs that are covered under Part B include, but not limited to:

Medications/Drugs (Outpatient/Part B)

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Durable Medical Equipment (DME) Supply Drugs

Payment may be made for supplies that are necessary for the effective use of durable medical equipment. This includes

drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the

durable medical equipment or to assure the proper functioning of the equipment. Refer to the Medicare Benefit Policy

Manual, Chapter 15, ¡ì110.3 ¨C Coverage of Supplies and Accessories.

Part B vs. Part D Guideline

Nebulizer Inhalation Drugs (e.g., Albuterol Sulfate, Ipratropium Bromide)

Certain inhalation drugs are generally covered under Part B when used with a nebulizer in the home. These drugs would

not be covered under Part D for use with a nebulizer. However, if these drugs were delivered with a metered dose inhaler

or other non-nebulized administration, they would be Part D drugs.

In the case of a member in a hospital, or a SNF bed, (1) who does not have Part A coverage, (2) whose Part A coverage

for the stay has run out or (3) whose stay is non-covered-infusible DME supply drugs are not covered under Part B

because the law limits coverage under Part B¡¯s DME benefit to those items that are furnished for use in a patient¡¯s home,

and specifies that a hospital or SNF cannot be considered the member¡¯s ¡°home¡± for this purpose. In this case, coverage

for the drugs would be available under Part D.

In addition to a hospital, a SNF or a distinct part SNF, the following facilities cannot be considered a home for purposes of

receiving the Medicare DME benefit:

A nursing home that is dually certified as both a Medicare SNF and a Medicaid nursing facility (NF); and

A Medicaid-only NF that primarily furnishes skilled care; and

A non-participating nursing home (i.e., neither Medicare or Medicaid) that provides primarily skilled care; and

An institution which has a distinct part SNF and which also primarily furnishes skilled care.

Refer to the Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C ¨C Medicare Part B versus Part D

Coverage Issues.

For the list of nebulizer drugs covered under Part B, refer to the DME MAC LCD for Nebulizers (L33370). Compliance with

these policies is required where applicable.

(Accessed May 21, 2024)

Infusion Pump Medications (e.g., Some Chemotherapeutic Agents)

In general, the supplier would bill Part B if the drug was Administered using an infusion pump and bill the Part D plan for

infusion using other methods (e.g., IV push). While professional services and supplies related to the administration of the

infused drug are not payable under Part D, some coverage may be available under Part A or B home health benefits,

under Medicaid, or from secondary commercial health benefits.

As a rule, drugs infused using an implantable pump would be covered under Part B. Drugs infused in the home using an

external pump are covered under Part B if they are included under the local coverage policy of the applicable Medicare

DME MAC.

In the case of a member in a hospital, or a SNF bed, (1) who does not have Part A coverage, (2) whose Part A coverage

for the stay has run out or (3) whose stay is non-covered infusible DME supply drugs are not covered under Part B

because the law limits coverage under Part B¡¯s DME benefit to those items that are furnished for use in a patient¡¯s home,

and specifies that a hospital or SNF cannot be considered the member¡¯s ¡°home¡± for this purpose. In this case, coverage

for the drugs would be available under Part D.

In addition to a hospital, a SNF or a distinct part SNF, the following facilities cannot be considered a home for purposes of

receiving the Medicare DME benefit:

A nursing home that is dually certified as both a Medicare SNF and a Medicaid nursing facility (NF); and

A Medicaid-only NF that primarily furnishes skilled care; and

A non-participating nursing home (i.e., neither Medicare or Medicaid) that provides primarily skilled care; and

An institution which has a distinct part SNF and which also primarily furnishes skilled care.

Refer to the Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C ¨C Medicare Part B versus Part D

Coverage Issues. (Accessed May 21, 2024)

Medications/Drugs (Outpatient/Part B)

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Immunosuppressive Drugs

Immunosuppressive drug therapy following a Medicare covered organ transplant is covered.

Covered drugs include those immunosuppressive drugs that have been specifically labeled as such and approved for

marketing by the FDA. (This is an exception to the standing drug policy which permits coverage of FDA Approved Drugs

for non-labeled uses, where such uses are found to be reasonable and necessary in an individual case.)

Immunosuppressive drugs are substances that suppress or interfere with normal immune responses. They are used in

controlling autoimmune diseases and in enhancing the chances for survival of foreign-tissue grafts and transplants.

Examples of FDA-approved immunosuppressive drugs include, but are not limited to:

Sandimmune (cyclosporine), Sandoz Pharmaceutical

Imuran (azathioprine), Burroughs Welcomes

Agma (antithymocyte globulin), Upjohn

Orthoclone OKT3 (Muromonab-CD3), Ortho Pharmaceutical

Prograf (tacrolimus), Fujisawa USA, Inc.

Celicept (mycophenolate mofetil), Roche Laboratorie

Daclizumab (Zenapax

Cyclophosphamide (Cytoxan)

Prednisone and Prednisolone

Notes:

Prescription drugs, such as prednisone, used in conjunction with immunosuppressive drugs as part of a therapeutic

regimen are covered as reflected in FDA approved labeling for immunosuppressive drugs. Therapeutic regimen is a

combination of drugs which has been clinically recognized for the treatment of a specific type of disorder or to treat

toxicities or side effects of drugs which are used at different times following an approved transplant.

Immunosuppressive drugs for organ transplants are covered under Part B coverage except when furnished during an

inpatient stay or upon discharge from the hospital, then the drugs are covered as Part A.

CMS expects contractors to keep informed of FDA additions to the list of the immunosuppressive drugs.

Members may have additional coverage for immunosuppressive drugs under the Part D Prescription Drug Plan which

are not covered in this benefit interpretation policy. Refer to the Member¡¯s Pharmacy Booklet or contact the

Prescription Solutions Customer Services Department to determine coverage eligibility for prescription drug plan

benefit.

Refer to the Medicare Benefit Policy Manual, Chapter 15, ¡ì50.5.1 ¨C Immunosuppressive Drugs.

(Accessed May 21, 2024)

Part B vs. Part D Guideline

Part B would be billed if the individual had a Medicare-covered transplant; otherwise, the Part D plan would be billed.

Pharmacists would bill Part B or the individual¡¯s Part D plan based on information received from the individual or the Part

D plan. Part B would be billed if the individual had a Medicare-covered transplant; otherwise, the Part D plan would be

billed. Part D plan eligibility systems could contain a marker for members who had a Medicare covered transplant. This

information could come from a question included on the Part D sponsor¡¯s enrollment or coordination of benefit (COB)

survey form.

In determining whether to pay for an immunosuppressive drug under Part D, it would not be appropriate for a Part D

sponsor to institute a general policy of requiring a Part B claim rejection, as a substitute for maintaining information on

transplant status and paying claims based on that information. Such a policy would be disruptive to beneficiaries and

pharmacies and would unnecessarily increase Part B contractor costs. Instead, a prior authorization requirement would be

appropriate.

Refer to the:

Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C ¨C Medicare Part B versus Part D Coverage

Issues.

Coverage Summary titled Organ and Tissue Transplants.

(Accessed May 21, 2024)

Medications/Drugs (Outpatient/Part B)

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Part B vs. Part D Guideline

Hemophilia blood clotting factors would not be a Part D benefit because of the Part B coverage. Refer to the Medicare

Prescription Drug Benefit Manual, Chapter 6, Appendix C ¨C Medicare Part B versus Part D Coverage Issues.

(Accessed May 21, 2024)

Oral Anti-Cancer Drugs and Oral Anti-Emetics

Oral anti-cancer drugs and oral anti-nausea (anti-emetic) drugs are covered when criteria are met.

For detailed coverage requirements, refer to the Medicare Benefit Policy Manual, Chapter 15, ¡ì50.5.3 Oral Anti-Cancer

Drugs.

For claims payment and coding information, refer to the Medicare Claims Processing Manual, Chapter 17, ¡ì80.1 Oral

Cancer Drugs.

Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) exist and compliance with these policies is

required where applicable. These LCDs/LCAs are available at .

Note: Members may have additional coverage for oral anti-cancer under the Part D. Prescription Drug Plan, which are not

covered in this coverage summary. Refer to the member¡¯s pharmacy booklet or contact the Prescription Solutions

customer service department to determine coverage eligibility for prescription drug plan benefit.

(Accessed May 21, 2024)

Part B vs. Part D Guideline

Certain oral chemotherapy agents used in cancer treatment for which there is an infusible version of the drug.

Pharmacists would need to determine the reason for treatment. If related to cancer treatment, Part B would be billed;

otherwise, the Part D plan should be billed.

To the extent that a Part B-covered oral anti-cancer drug has no other medically accepted indication besides cancer

treatment, Part D sponsors should not include these drugs on their formularies because of Part B coverage. For the

drugs that have other medically accepted indications, prior authorization programs or other mechanisms to obtain

diagnostic information could be used to ensure appropriate payment.

Oral anti-emetics used in cancer treatment as a full replacement for intravenous treatment.

Pharmacists would need to determine the reason for treatment. If both related to cancer treatment and a full

replacement for intravenous administration within 48 hours of cancer treatment, Part B would be billed; otherwise, the

Part D plan should be billed.

Note: In order to receive Part B payment, CMS currently requires that the prescribing physician indicate on the

prescription that the oral anti-emetic is being used ¡°as a full therapeutic replacement for an intravenous anti-emetic

drug as part of a cancer chemotherapeutic regimen.¡±

If based on a prior authorization program or other mechanism to obtain diagnostic information, a Part D sponsor

determined that a) a Part B-covered oral anti-emetic was being billed, and b) the drug was being furnished in the

context of cancer treatment for use within 48 hours of cancer treatment, the Part D sponsor should deny payment.

Such drugs dispensed for use after the 48-hour period, or any oral anti-emetic prescribed for conditions other than the

effects of cancer treatment, would be Part D drugs.

Refer to the Medicare Prescription Drug Benefit Manual, Chapter 6, Appendix C ¨C Medicare Part B versus Part D

Coverage Issues. (Accessed May 21, 2024)

Immunizations

Immunizations (e.g., pneumococcal vaccine, Hepatitis B vaccine, and influenza vaccine) are covered when criteria are

met. Refer to the Medicare Benefit Policy Manual, Chapter 15, ¡ì50.4.4.2 ¨C Immunizations for coverage criteria.

(Accessed May 21, 2024)

Part B vs. Part D Guideline

For Hepatitis B vaccine, physicians would need to determine the level of risk of the individual. If the individual is at high or

intermediate risk, Part B would be billed. For all other individuals, prior authorization programs could be used to ensure

appropriate level of risk.

Medications/Drugs (Outpatient/Part B)

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